PreSep Oligon Oximetry Catheter— 510(k) K160645

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K160645 for PreSep Oligon Oximetry Catheter, Substantially Equivalent on 2016-06-16. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DQE
Advisory panel: Cardiovascular
Date received: 2016-03-07
Decision date: 2016-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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